Study on Children Henoch-Schönlein Purpura Nephritis With TCM Multistep Treatment

Henan University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Henoch-Schönlein Purpura Nephritis

Treatments: Drug: Chinese herbs based on syndrome differentiation; Drug: Sulfotanshinone Sodium Injection; Drug: Dipyridamole Tab 25 MG; Drug: Benazepril Hydrochloride Tablets; Drug: Glycosides Of Tripterygium Wilfordii Hook(GTW); Drug: Prednisone Acetate Tablets; Drug: Chinese medicine placebo; Drug: Low Molecular Weight Heparin Calcium Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03591471

TCM for Children HSPN

2013BAI02B07 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to determine the optimum dosage and application method of Glycosides Of Tripterygium Wilfordii Hook(GTW) for Henoch-Schönlein Purpura Nephritis(HSPN) in children, and develop into the normal treatment protocols for Henoch-Schönlein Purpura Nephritis in children.

Full description

Based on Chinese Eleventh Five-year Plan for Science and Technology Program, this study follows a large-sample multicenter centerrandom open-label controlled perspective method, enrolls HSPN children with hematuria associated with proteinuria and isolated proteinuria from 2 to 18 years of age, classifys five traditional Chinese medicine patterns of syndrome: wind-heat complicated with blood stasis, blood-heat complicated with blood stasis, yin deficiency complicated with blood stasis, both qi and yin deficiency complicated with blood stasis,damp-heat complicated with blood stasis. For TCM group,according to the severity of HSPN, stepped treatment should be taken. The initial dosage of GTW for severe HSPN is 2mg/kg/d, continued with 1.5mg/kg/d and 1mg/kg/d; The initial dosage of GTW for light HSPN is 1.5mg/kg/d, continued with 1mg/kg/d. On the above base, the comprehensive treatment are taken combined with TCM syndrome differentiation, medicated with Sulfotanshinone Sodium Injection.For controlled group,the treatment for severe HSPN is prednisone combined with heparin plus lotensin and dipyridamole tablets;for light HSPN is heparin plus lotensin and dipyridamole tablets.12 weeks after treatment, the third-party statistics evaluate the efficacy and effect,and a follow-up lasting 36 weeks will go on.

Enrollment: 500 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Henoch-Schönlein Purpura Nephritis Disease
• Age form 2-18 years old
• Disease onset within 2 months

Exclusion criteria

• Nephritis not causing by HSPN
• Being alergic to the medicine in the treatment
• No compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

TCM multistep therapy

Experimental group

Description:

Light HSPN:1.Glycosides Of Tripterygium Wilfordii Hook(GTW): initial dosage is 1.5mg/kg/d(4 weeks),continued with 1mg/kg/d(8 weeks),12weeks in total. Severe HSPN:1.GTW:the initial dosage is 2mg/kg/d(2 weeks), continued with 1.5mg/kg/d(2 weeks) and 1mg/kg/d(8 weeks); 12weeks in total. On the above base,Sulfotanshinone Sodium Injection(1mg/kg/d,2weeks) and Qingrezhixue granules(a nosocomial preparation) combined with Chinese herbs(12weeks) based on TCM syndrome differentiation are taken at the same time.

Treatment:

Drug: Sulfotanshinone Sodium Injection

Drug: Chinese herbs based on syndrome differentiation

Drug: Glycosides Of Tripterygium Wilfordii Hook(GTW)

Routine medicine

Active Comparator group

Description:

Light HSPN:1.Lotensin: 5-10mg/d,12weeks; 2.Low Molecular Weight Heparin(LMWH):100u/kg,2weeks;3.Dipyridamole:3mg/kg/d,Tid,12weeks.4.Chinese medicine placebo,12weeks. Severe HSPN:Add pednisone on the treatment of Light HSPN,and gradually reduce the dosage in 12 weeks,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinued（Reduce the dosage at the rate of 5mg every other day in 4-8 weeks，then reduce the dosage at the rate of 5-10mg per week in 8-12weeks）

Treatment:

Drug: Low Molecular Weight Heparin Calcium Injection

Drug: Chinese medicine placebo

Drug: Dipyridamole Tab 25 MG

Drug: Benazepril Hydrochloride Tablets

Drug: Prednisone Acetate Tablets